Strong CRA Needed (Associate/Manager Clinical EDC Systems)

Major Duties and Responsibilities: Develop and maintain procedures and documents that describe the responsibilities of Clinical Program Management (CPM) staff in the conduct of clinical trials performed in EDC, and provide advice and guidance to clinical project teams conducting studies in EDC. This position will be a full time member of the EDC Core Team, with dotted line reporting to the head of the EDC Core Team.Major duties and responsibilities include but are not limited to: 1. Acts as an advisor/mentor to all members of project teams using EDC as the method of data collection and management, with particular emphasis on the CPM staff, to facilitate: • Effective remote monitoring • Timely data review • Resolution of site issues • Assessment and execution of site provisioning, as needed2. Works with clinical project teams to develop and maintain standardized process flow diagrams, SOPs, WPDs, and other procedures and documents that describe the responsibilities of CPM staff in the conduct of clinical trials performed in EDC.3. Supports CPM staff in developing/using User Acceptance Testing (UAT) of the eCRF.4. Develops/assists in development of EDC training materials with emphasis on the roles of CPM staff.5. Provides assistance in delivering training sessions to both internal (CPM, Medical Directors, CRAs, CRO staff) and external (Investigators, Study Coordinators) EDC users as needed.6. Works closely with project teams to ensure clinical trials are conducted according to current EDC procedures.7. Develops MedImmune best practices and participates in standards development and maintenance.8. Holds CPM functional area lessons learned meetings, as appropriate, and maintains action item list.9. Attends EDC portions of Clinical Project Team Meetings for projects conducted in EDC, with particular emphasis on the EDC events in the MS Project Timeline for the project.10. Assists in the development of performance metrics for clinical study teams and site staff. Collects and distributes metric data for clinical staff and provides assessment of areas for investigation and/or training. Requirements/Qualifications:Education: BA/BS in a scientific or technical field or equivalent experience Experience: Minimum of 5 years clinical research experience as a CRA, Senior CRA or equivalent, including experience in EDC clinical trialsSpecial Skills/Abilities: • Prior experience with EDC systems • Proficiency in Microsoft Office • Detail oriented with excellent organizational skills, communication and interpersonal skills • Demonstrated collaboration and negotiation skills • Ability to work in a matrix environmentJob Complexity: Moderate - complexSupervision: • Must be able to work with minimal supervision • Must be confident in making decisions within the scope of the responsibility of the position  MedImmune, Inc. is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law. Job Title: Strong CRA Needed (Associate/Manager Clinical EDC Systems) Company:  MedImmune Inc. Location:  Gaithersburg, MD 20878 Status:  Full Time, Employee Job Category:  Biotech/R&D/Science Company: MedImmune Inc.